Additional Resources

CHAPTER SECTIONS

Data and Safety Monitoring


Section 10


Additional Resources

Contributors

Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD

 

Contributing Editor

Gina Uhlenbrauck

Resource Description
Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH, and Susan Ellenberg, PhD) December 8, 2017, PCT Grand Rounds presentation, available as a webinar, slide set, and podcast.
Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical
Trials: A Practical Perspective. Volume 6. Wiley (Second edition scheduled 2019)		 Provides a practical overview of data monitoring in clinical trials, including the purpose, responsibilities, and operation of DMCs. Useful for those managing and conducting clinical trials and those serving on DMCs or regulatory and ethical committees.
DeMets DL, Furberg CD, Friedman LM. Data Monitoring in Clinical Trials: A Case Studies
Approach. Springer; 2006.		 A collection of cases are used to explore issues in data monitoring of clinical trials.
CTTI’s DMC recommendations While not specific to ePCTs, the recommendations address the role of the DMC, DMC composition, communication among DMC members and other stakeholders, the DMC charter, and issues related to DMC training.
Ethical and Regulatory Issues in Pragmatic Clinical Trials: Special Issue of Clinical Trials This page provides background and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in the special issue of Clinical Trials describes an issue in detail (e.g., privacy, informed consent) and, where possible, attempts to provide guidance for future pragmatic clinical trials.

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SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Which PCTs Should Have a DMC?
  3. Monitoring Protocol Adherence
  4. Data Issues With Monitoring PCTs
  5. Monitoring for Serious Adverse Events
  6. Futility Assessment
  7. Case Study: Planning for Monitoring PCTs
  8. Including Stakeholder Perspectives
  9. Special Training and Resources for DMCs of Pragmatic Trials
  10. Additional Resources
  11. Futility Assessment – ARCHIVED


Version History

December 13, 2018: Updated resource table as part of annual content update (changes made by L. Wing).

Published August 25, 2017

current section :

Additional Resources

  1. Introduction
  2. Which PCTs Should Have a DMC?
  3. Monitoring Protocol Adherence
  4. Data Issues With Monitoring PCTs
  5. Monitoring for Serious Adverse Events
  6. Futility Assessment
  7. Case Study: Planning for Monitoring PCTs
  8. Including Stakeholder Perspectives
  9. Special Training and Resources for DMCs of Pragmatic Trials
  10. Additional Resources
  11. Futility Assessment – ARCHIVED

Citation:

Ellenberg S, Sugarman J, Zatzick D. Data and Safety Monitoring: Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/planning-data-safety-monitoring/additional-resources/. Updated December 13, 2018. DOI: 10.28929/048.